A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease

McGill University Health Centre/Research Institute of the McGill University Health Centre2,130 enrolled

Overview

This study aims to identify and assess new CMR techniques that can improve current CMR protocols.

The aim of this study is to develop a comprehensive 10-minute protocol based on function and myocardial tissue characterization without the need for contrast injection, which can be standardized for 70% of cardiac patients. To test this 10-minute CMR protocol for its ability to significantly improve diagnostic decision-making and to reduce cost. To test its clinical feasibility, performance and cost-effectiveness in different populations including: Non-ischemic cardiomyopathies (-)OS-CMR and Ischemic Heart Disease and CAD (+)OS-CMR

Study Type

OBSERVATIONAL

Enrollment

2,130

Conditions

Coronary Artery Disease Myocarditis Infiltrative Cardiomyopathy Dilated Cardiomyopathy Hypertrophic Cardiomyopathy Aortic Valve Stenosis Aortic Valve Regurgitation

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Healthy Volunteers Inclusion Criteria: * Age: \> 18y, Informed consent No known current or pre-existing significant medical conditions that would affect the cardiovascular or respiratory system Exclusion Criteria: * General MRI contraindications: MR- incompatible devices such as pacemakers, defibrillators, or implanted material or foreign bodies. Consumption of caffeinated drinks or foods (including cocoa and chocolate) during the 12 hours prior to the exam.Regular nicotine consumption during the last 6 months Patients Inclusion Criteria: * Age: \>18 y, Informed consent, Clinically indicated CMR exam Exclusion Criteria: * General MRI contraindications: MR- incompatible devices such as pacemakers, defibrillators, or implanted material or foreign bodies Vasoactive medication (e.g. nitro) during the 12 hours prior to the exam. Consumption of caffeinated drinks or foods (including cocoa and chocolate) during the 12 hours prior to the exam. Regular nicotine consumption during the last 6 months

Outcomes

Primary Outcomes

Primary diagnosis comparison between SMART CMR and standard CMR

(All patients) Agreement of the suggested primary diagnosis derived from SMART CMR, compared with the diagnosis established from standard CMR protocols, using the final clinical diagnosis as established by the treating physician, as a standard of truth. If the latter is not available, the conclusions based on the results of the standard CMR protocol will be used as the standard of truth.

Time frame: 2019-2025

Main finding comparison between SMART CMR and standard CMR in patients with suspected coronary artery disease

(Patients with suspected coronary artery disease:) Agreement of the main finding regarding the presence of a coronary territory at risk for inducible myocardial ischemia myocardial derived from OS-CMR, compared with standard first-pass perfusion CMR, using the coronary angiography report as a standard of truth. If the latter is not available, the conclusions based on the results of the standard CMR first pass perfusion scan will be used as the standard of truth.

Time frame: 2019-2025

Secondary Outcomes

SMART CMR scan completion percentage

Proportion of SMART CMR scans that could be completed according to the protocol

Time frame: 2019-2025

OS-CMR scan completion percentage

Proportion of OS-CMR scans that could be completed according to the protocol

Time frame: 2019-2025

Adverse event monitoring during SMART CMR sequences

Number and proportion of reported adverse events effects during SMART CMR

Time frame: 2019-2025

Adverse event monitoring during OS-CMR sequence

Number and proportion of reported adverse events during OS-CMR

Time frame: 2019-2025

SMART CMR sequence times vs standard protocol sequence times

Observed scan time for SMART CMR compared with the standard CMR protocol

Time frame: 2019-2025

OS-CMR sequence times vs standard protocol sequence times

Observed scan time for for OS-CMR during breathing maneuvers compared with the standard CMR first-pass perfusion protocol

Time frame: 2019-2025

Cost comparison of SMART CMR vs standard CMR protocol

Total estimated cost of SMART CMR compared with the standard CMR protocol

Time frame: 2019-2025

Cost comparison of OS-CMR vs standard CMR protocol

Total cost of OS-CMR with breathing maneuvers (based on scan time) vs the standard CMR first-pass perfusion protocol (calculated from the scan time plus any other material such as contrast agents or pharmacological vasodilators)

Time frame: 2019-2025

Septal myocardial T1 vs standard myocardial T1

Septal myocardial T1 as estimated from SMART CMR, compared with results from standard myocardial mapping

Time frame: 2019-2025

Septal myocardial T2 vs standard myocardial T2

Septal myocardial T2 as estimated from SMART CMR, compared with results from standard myocardial mapping

Time frame: 2019-2025

Quantitative parameter comparison between SMART CMR and CINE images

Quantitative parameters relevant to the diagnosis (see Appendix: CanSCMR Recommendations for reporting CMR) measured in SMART CMR images, compared with results from standard CMR cine images

Time frame: 2019-2025

Strain measurements vs standard cine image measurements

Longitudinal and circumferential strain measurements measured in SMART CMR images, compared with results from standard CMR cine images

Time frame: 2019-2025

SMART-CMR post-stenotic peak flow vs standard CMR flow images

Post-stenotic peak flow velocity in patients with suspected valvular disease measured in SMART CMR images, compared with results from standard CMR flow images

Time frame: 2019-2025

Intra- and inter-reader reproducibility

Correlation coefficients will be obtained to evaluate the intra- and inter-reader reproducibility of all quantitative markers.

Time frame: 2019-2025

Inter- and intra-scanner variability

Inter- and intra- scanner variability as assessed by ICC and kappa

Time frame: 2019-2025

A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts